Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000272594
Ethics application status
Approved
Date submitted
15/06/2006
Date registered
3/07/2006
Date last updated
10/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A double-blinded, placebo-controlled trial of modafinil for amphetamine withdrawal
Scientific title
A double-blinded, placebo-controlled trial of modafinil for amphetamine withdrawal in adults who are currently dependent on amphetamines
Universal Trial Number (UTN)
Trial acronym
Modafinil Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amphetamine withdrawal 1248 0
Condition category
Condition code
Mental Health 1334 1334 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited via UnitingCare Moreland Hall and Drug and Alcohol Services, Western Hospital (DASWest). Participants will receive oral modafinil for seven days (tapering doses from 200mg for the first 5 days to 100mg for days 6 and 7).
Intervention code [1] 1144 0
Treatment: Drugs
Comparator / control treatment
Oral placebo (sugar pill) for seven days, tapering doses from 200mg for the first 5 days and 100mg for days 6 and 7
Control group
Placebo

Outcomes
Primary outcome [1] 1820 0
The two treatment groups will be compared for their symptoms of amphetamine withdrawal, including symptoms of depression and sleep disturbance, neuro-cognitive function, as well as any potential side effects from the medication.
Timepoint [1] 1820 0
These symptoms will be measured once a day, for the seven to ten day inpatient stay
Secondary outcome [1] 3186 0
1. To gain an understanding of the natural history of psychostimulant withdrawal in an inpatient setting, focusing on severity and duration of symptoms.
Timepoint [1] 3186 0
This will be measured every day of the seven to ten day inpatient stay
Secondary outcome [2] 3187 0
2. To examine the impact of offering withdrawal medication (modafinil) on retention in withdrawal treatment.
Timepoint [2] 3187 0
Measured every day of the seven to ten day inpatient stay

Eligibility
Key inclusion criteria
Meets the Diagnostic and Statistical Manual for Mental Disorders No. 4 (DSM-IV) diagnosis of current amphetamine dependence, Has used amphetamines in previous 48 hours, Is seeking treatment for amphetamine dependence, Is willing and able to give informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently dependent on other psychoactive drugs other than amphetamines, cannabis or nicotine, Has any significant unstable medical conditions, Is pregnant or breastfeeding, Is suffering from active psychosis or current major depression, Is diagnosed with attention deficit hyperactivity disorder or narcolepsy, Is known to have had an allergic reaction to modafinil previously, Has had treatment with dexamphetamine or modafinil in the previous month.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who will be off site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1459 0
Government body
Name [1] 1459 0
The Australian Government Department of Health and Aging.
Country [1] 1459 0
Australia
Primary sponsor type
Government body
Name
Government Department of Health and Aging.
Address
Department of Health and Ageing, Victorian Department of Human Services, Bourke St, Melbourne, 3000
Country
Australia
Secondary sponsor category [1] 1288 0
None
Name [1] 1288 0
Nil
Address [1] 1288 0
Country [1] 1288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2839 0
Melbourne Health-Drug and Alcohol Services, Western Hospital
Ethics committee address [1] 2839 0
Ethics committee country [1] 2839 0
Australia
Date submitted for ethics approval [1] 2839 0
Approval date [1] 2839 0
Ethics approval number [1] 2839 0
2006.103

Summary
Brief summary
The project aims to develop a greater understanding of amphetamine withdrawal and whether medication, such as modafinil, is effective in the management of amphetamine withdrawal in an inpatient setting. Participants will be randomised to a single morning dose of modafinil or matching placebo. Participants will receive medication for seven days (tapering doses from 200mg to 100mg). The two treatment groups will be compared for their symptoms of amphetamine withdrawal, including symptoms of depression and sleep disturbance, neuro-cognitive function, as well as any potential side effects from the medication. Other outcome measures will include retention in treatment and monitoring the rate of relapse to amphetamine use post withdrawal. This information will then inform guidelines for withdrawal management, including psychosocial and medical aspects. The protocol will be distilled for a clinical audience and include principles and practice, practice guidelines and recommendations for implementation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36086 0
Address 36086 0
Country 36086 0
Phone 36086 0
Fax 36086 0
Email 36086 0
Contact person for public queries
Name 10333 0
Amy Pennay
Address 10333 0
Turning Point Alcohol and Drug Centre
54-62 Gertrude Street
Fitzroy VIC 3065
Country 10333 0
Australia
Phone 10333 0
+61 3 84138460
Fax 10333 0
Email 10333 0
[email protected]
Contact person for scientific queries
Name 1261 0
Nicole Lee
Address 1261 0
Turning Point Alcohol and Drug Centre
54-62 Gertrude Street
Fitzroy VIC 3065
Country 1261 0
Australia
Phone 1261 0
+61 3 84138416
Fax 1261 0
Email 1261 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe Effects of Modafinil Treatment on Neuropsychological and Attentional Bias Performance During 7-Day Inpatient Withdrawal From Methamphetamine Dependence2010https://doi.org/10.1037/a0021791
N.B. These documents automatically identified may not have been verified by the study sponsor.